FDA Inspection 596008 — LasikPlus
The FDA completed an inspection of LasikPlus on July 14, 2009 in Louisville, KY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 14, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Louisville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |
| 642 | 21 CFR 803.18(b)(1)(i) | Adverse events--all info not in file |
| 658 | 21 CFR 803.30(a)(2) | Report of Serious Injury Within 10 Days |
| 712 | 21 CFR 803.33(a) | Failure to Submit Annual Reports |